Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Keratome, Ac-Powered
510(k) Number K935342
Device Name SCMD KERATOME
Applicant
S.C.M.D. Keratomes of Arizona
16833 E. Parlin Dr.
Ftn. Hills,  AZ  85268
Applicant Contact C RICHARD SMITH
Correspondent
S.C.M.D. Keratomes of Arizona
16833 E. Parlin Dr.
Ftn. Hills,  AZ  85268
Correspondent Contact C RICHARD SMITH
Regulation Number886.4370
Classification Product Code
HNO  
Date Received11/05/1993
Decision Date 04/01/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-